BEIJING, June 11, 2012 /PRNewswire-Asia/ -- Sinovac Biotech Ltd. (Nasdaq: SVA), a leading provider of biopharmaceutical products in China, today announced a positive SFDA inspection of the three clinical trial sites being used in the Company's Phase III study of its proprietary inactivated Enterovirus 71 (EV71) vaccine against hand, foot and mouth disease (HFMD).
In May 2012, an expert from the Center for Drug Evaluation within the State Food and Drug Administration (SFDA) completed an inspection of the three Phase III study sites in Jiangsu Province, as well as the central laboratories set up by the Chinese Center for Disease Control and Prevention (CDC), according to the Good Clinical Practice (GCP) guidelines. As part of the inspection, study investigators from the three sites presented reports on the site's procedures of vaccination, safety monitoring and case surveillance, and the EV71 epidemic situation. The inspector also assessed the management systems at the three central laboratories, and their compliance with standard operating procedures.
After the inspection, the SFDA expert positively acknowledged the comprehensive surveillance work performed by the clinical sites, and confirmed its importance to the clinical evaluation of the EV71 vaccine. Additionally, the SFDA expert indicated that the site inspection would facilitate further interaction between the SFDA and the investigators to solve any problems or issues that may arise during the study period, which will be beneficial as the Company advances through the regulatory process.
Dr. Weidong Yin, Chairman, President and CEO, said, "With no specific treatments for EV71 and no effective prevention methods, we are continually reminded of the importance of rapidly developing a high quality vaccine against Enterovirus71. By simultaneously conducting the EV71 vaccine Phase III trial, maintaining ongoing discussions with the SFDA and preparing our dedicated production facility, we intend to address this unmet need by being well positioned to provide this vaccine to our children soon after it is approved. We remain on track to complete Phase III of the trial before the middle of next year."
Sinovac Biotech Ltd. is a China-based biopharmaceutical company that focuses on the research, development, manufacturing and commercialization of vaccines that protect against human infectious diseases including hepatitis A and B, seasonal influenza, H5N1 pandemic influenza (avian flu) and H1N1 influenza (swine flu), as well as animal rabies vaccine for canines. In 2009, Sinovac was the first company worldwide to receive approval for its H1N1 influenza vaccine, Panflu.1, and has manufactured it for the Chinese Central Government, pursuant to the government-stockpiling program. The Company is also the only supplier of the H5N1 pandemic influenza vaccine to the government-stockpiling program. Sinovac is developing a number of new pipeline vaccines including vaccines for Enterovirus71 (against hand, foot and mouth disease), pneumococcal conjugate, pneumococcal polysaccharides, mumps and rubella. Sinovac sells its vaccines mainly in China and exports selected vaccines to Mongolia, Nepal, and the Philippines.
Safe Harbor Statement
This announcement contains forward-looking statements. These statements are made under the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by words or phrases such as "will," "expects," "anticipates," "future," "intends,""plans," "believes," "estimates" and similar statements. Among other things, the business outlook and quotations from management in this press release contain forward-looking statements. Statements that are not historical facts, including statements about Sinovac's beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of important factors could cause actual results to differ materially from those contained in any forward-looking statement. Sinovac does not undertake any obligation to update any forward-looking statement, except as required under applicable law.
Helen Yang/Chris Lee
Sinovac Biotech Ltd.